A dual prong nasal cannula is generally used to deliver oxygen to a patient via the patient's nose. The most commonly used arrangement includes a dual prong nosepiece that is centered in a loop of vinyl tubing. The nosepiece prongs are inserted into the patient's nostrils with the tubing tucked behind the ears and then extending around to the front of the patient below the chin. A slide adjustment may be used to draw the tubing tight beneath the chin. Usually by the third or fourth day of using a dual prong nasal cannula, the skin and subcutaneous areas in contact with the cannula prongs and tubing become irritated. By the fifth day, the majority of patients begin to use tissues and the like to relieve the soreness, pressure and irritation under the nose and around the ears. This soreness, pressure and irritation is often due to abrasion and interface pressure, which is caused by continuous movement of the tight fitting tubing and cannula prongs and the accumulation of moisture between the skin and the tubing and/or cannula prongs. As the slide adjustment is pulled tighter to keep the cannula prongs positioned in the nostrils of the patient, the irritation is only exacerbated and the subcutaneous layers of the skin are affected.
Thus, the use of a conventional dual prong cannula can become quite uncomfortable for a patient and can lead to pressure ulcers at contact points. The comfort of the patient becomes even more critical, both to the patient and to the professionals attending the patient, when the patient is also fitted with a naso-gastric or Levine tube. In this event, the nose becomes a fairly cluttered access route, and adhesive tape is often used, by application to the face, to position all the tubes and secure them in place.
In addition to the discomfort and susceptibility to skin deterioration where supplemental oxygen is required, a patient may also suffer from “free floating anxiety” as a result of reduced blood oxygen. Such a patient may believe something is wrong but cannot quite identify the problem, and may not be thinking clearly. Often such patients have feelings of claustrophobia and may attempt to remove the nasal cannula despite the resulting adverse impact on the patient's condition. It is not uncommon to find the tubing disconnected or the cannula prongs displaced from the nose due to pulling on the cannula that results from the movement of the patient's head, especially during sleep. Further, patient non-compliance or lack of cooperation, resulting from irritation and discomfort caused by a nasal cannula, may necessitate the use of some more expensive or aggressive means of oxygen administration, including face masks or catheters.
To an increasing extent, supplemental oxygen is used on an outpatient basis, such as in a patient's home. Under such conditions, the cosmetic appearance of the oxygen delivery apparatus can be important, and the commonly-used dual prong cannula can make a person feel conspicuous and, as previously mentioned, cause irritation from interface pressure.
In addition to the discomfort, skin deterioration, and cosmetic concerns posed by use of dual prong cannulas, it has been established that using a single prong nasal cannula, or a unilateral, nasal catheter will provide a higher inspired oxygen fraction than a dual prong nasal cannula.
Furthermore, certain prior art gas delivery system designs have resulted in irritation and/or discomfort to the patient. For example, in the mid-1980's the medical industry relied on EKG patches to stabilize oxygen tubes and secure the end of a single prong cannula within the patient's nostril. While the EKG patches used a glue or adhesive that worked fine for EKGs, the EKG patches did not function well for use as a stabilization patch for securing oxygen tubing to the facial skin of a patient. When the EKG patches were used with gas delivery systems for extended periods of time, there was a risk that the adhesive could pull the patient's skin off upon removal of the stabilization patch, especially the skin of infants or elderly people.
When using prior art gas delivery systems, health care providers encountered difficulty with securing the plastic tubing component of the gas delivery systems to the patient's face. After the plastic tubing adapted to the patient′ skin temperature, the plastic tubing become softer and lose integrity. This problem was amplified when the gas delivery system was used with patients having a fever, particularly with high temperatures, for example, of 101 degrees to 103 degrees. Once the plastic tubing lost its integrity, the cannula prongs would no longer be supported by the tubing and would fall out of the patient's nostril. A need exists for a gas delivery system that includes a mechanism for maintaining the tubing shape and integrity as the temperature of the tubing rises due to the patient's skin temperature.
Therefore, a need exists for a gas delivery device having a single prong nasal cannula, or a single prong gas delivery device, that can be securely and comfortably affixed to a patient while providing an adequate supply of oxygen or other gas to the patient with the least amount of irritation and/or discomfort to the patient possible and overcoming the problems associated with prior art oxygen nasal cannulas.
The relevant prior art includes the following references:
Patent No.InventorIssue/Publication Date(U.S. Patent References)4,660,555PaytonApril 28, 19874,685,456SmartAugust 11, 19874,736,741Payton et al.April 12, 19884,742,824Payton et al.May 10, 19886,804,866Lemke et al.October 19, 20046,807,966WrightOctober 26, 2004WO2005/014080WoodFebruary 17, 20056,913,017RobertsJuly 05, 20052008/0223375Cortez et al.September 18, 2008D643,113ButlerAugust 9, 2011